Skip to content

Intera I/T

by Philips Medical Systems North America Co.

510(k) K013344

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013344 Date11 Dec 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0885-2019 FDA Class II initiated 21 Dec 2018

    There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.

    • Terminated Z-1024-2016 FDA Class II initiated 6 Jul 2015

    Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Philips Medical Systems North America, Inc.

See all devices from Philips Medical Systems North America, Inc. →